Zevra Therapeutics, Inc. · NASDAQ:ZVRA
Zevra Therapeutics — FY2022 Earnings Presentation
26 slides from Zevra Therapeutics's earnings presentation, Mar 7, 2023
Slide 1: Q4 and FY 2022 Results
Q4 and FY 2022 Results March 7, 2023 SZEVRA THERAPEUTICS Trademarks herein are held by their respective owners.
Slide 2: Cautionary Note Regarding Presentation Information
VA SSSANY Cautionary Note Regarding Presentation SAZEV Information This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current
Slide 3: Agenda
Agenda SZEVRA THERAPEUTICS Strategic Overview, 2022 Highlights & Program Updates Richard W. Pascoe, CEO AZSTARYS® Commercial Update, 2022 Financial Results & 2023 Financial Guidance R. LaDuane Clifton, CFO, Secretary & Treasurer Upcoming Milestones & 2023 Outlook Richard W. Pascoe, CEO Q&A Richard W
Slide 4: We are Zevra Therapeutics
SZEVRA We are Zevra THERAPEUTICS
Slide 5: Our Strategic Evolution
ACA SSSSSANN Our Strategic Evolution EVALUATE >> STRATEGIZE >> EVOLVE Responding to market dynamics, stakeholder demand, and changing technologies and circumstances to ensure relevance, progress and prosperity
Slide 6: Significant Value-Creation Opportunity in Rare Disease for Patients and Shareholders
LZ \\ Significant Value-Creation Opportunity in GZEV Rare Disease for Patients and Shareholders THERAPEUTICS Unique partnerships with patient Longer market exclusivity and less communities generic competition 7 Lower cost of R&D Regulatory and financial incentives Shorter development timelines Sine
Slide 7: Why Zevra Therapeutics?
Why Zevra Therapeutics? Zevra, Greek for zebra, is the internationally recognized symbol for the rare disease community SZEVRA THERAPEUTICS
Slide 8: Positioned for Success
2\A\A SAN Positioned for Success THERAPEUTICS Strategic focuson rare diseases Arimoclomol: treatment of Niemann-Pick disease Typec (NPC) KP1077: treatment of jopathic hypersomnia (IH) and narcolepsy Other product opportunities Strong balance sheet Build a highly differentiated pipeline of developmen
Slide 9: 2022 Highlights
VA SSSANY 2022 Highlights SZEVRA THERAPEUTICS + 5/45: Arimoclomol acquisition + Completion of 4-year safety trial + Ongoing collaborative dialogue and periodic meetings with the FDA 4/19: Phase 1 SDX cardiovascular safety trial initiation 5/5: IND submitted for Phase 2 study in idiopathic hypersomni
Slide 10: Q4 2022 and Recent Highlights
Q4 2022 and Recent Highlights eas is | Matthew Plooster Corporate Ghinoraia November 18, 2022 Board Chairman Fob 99.5003 Mg Richard W. Pascoe eDrUary.£4. February 28, 2023 Orphan Drug Chief Executive Officer Designation received for Joshua Schafer, Company Joined NORD treatment of IH Chief Commercia
Slide 11: SZEVRA
SZEVRA THERAPEUTICS Richard Pascoe Travis Mickle, Ph.D. R. LaDuane Clifton Sven Guenther, Ph.D. Christal Mickle Joshua Schafer CEO President & Co-Founder CFO, Secretary & Treasurer Chief Scientific Officer Chief Product Development Chief Commercial Officer & Co-Founder Officer & EVP of BD Matthew R.
Slide 12: Arimoclomol
ARIMOCLOMOL For the Treatment of Niemann-Pick Disease Type C (NPC)
Slide 13: Arimoclomol — Innovative Product for a High Unmet Need
4.1. _Saa\\ Arimoclomol — Innovative Product for a SIZEV High Unmet Need ge ©) FIRST-IN-CLASS, ORAL @) EXTENSIVELY RESEARCHED BENET IC RREGULATORY: TREATMENT INTENDED FOR NPC POSITIONING » Capsule formulation designedto be » Studied in ten Phase 1, four Phase 2, » Orphan Drug Designation for NPC. sw
Slide 14: Near-Term Opportunity to Commercialize Arimoclomol and Retain Full Market Value
Near-Term Opportunity to Commercialize EV and Retain Full Market Value Small & nimble Market entry through commercial team U.S. and E.U. EAPs Launch arimoclomol with a small, focused commercialization effort : Commercial which can be foundation a CTE opportunities outside for future rare disease P t
Slide 15: SDX Product Candidate: KP1077
SDX PRODUCT CANDIDATE: KP1077 For the Treatment of Idiopathic Hypersomnia (IH)
Slide 16: KP1077 — Multiple Clinical Programs Targeting Rare Sleep Indications
AC SSaANN KP1077 — Multiple Clinical Programs SIZEVRA Targeting Rare Sleep Indications KP1077 Represents a Potential “Portfolio in a Pill” Opportunity » Lead KP1077 indication » Investigational New Drug (IND) application cleared by FDA * Ongoing phase 2 clinical trial was initiated in December 2022
Slide 17: AZSTARYS Commercialization Update
AZSTARYS® Commercialization Update d-Methylphenidate Prodrug Product for the Treatment of ADHD
Slide 18: AZSTARYS Prescription Trends Are Encouraging
SZEVRA AZSTARYS® Prescription Trends Are 7 THERAPEUTICS Encouraging Potential to achieve one or more sales milestones based on current trend AZSTARYS TRx Since Launch’ Week ending Feb 24, 2023 6,878 TRx Meaningful change in trend 5,000 line beginning Q3 2022 ——————___ Week ending Jul 8, 2022 1,542 T
Slide 19: AZSTARYS Provides a Foundation
ACA 1 SSSANN AZSTARYS® Provides a Foundation THERAPEUTICS Royalties from legacy develop/out-license model may not be a strong growth driver in short or medium term Q3 2021 $0.03M 2022, with coverage at three largest PBMs and ~175 field reps in the field Q4 2021 5,189 5,686 $0.06M (as reported by Cor
Slide 20: Financial Update
SZEVRA THERAPEUTICS FINANCIAL UPDATE
Slide 21: Financial Position is a Source of Strength
Financial Position is a Source of Strength THERAPEUTICS Q4 and FY 2022 Results: + Net Revenue: * Q4 2022 was $2.3M; FY 2022 was $10.5M, derived primarily from the French EAP program, royalties and consulting service fees + Net Loss Attributable to Common Stockholders: * Q4 2022 was ($9.0M), or ($0.2
Slide 22: 2023 Financial Guidance
2023 Financial Guidance THERAPEUTICS Cash balance remains strong, with potential to realize milestone revenue Available cash, cash equivalents and investments expected to extend cash runway into 2026 * Current operating plan includes the expected reimbursements from the French arimoclomol EAP, the f
Slide 23: Outlook for 2023 and Beyond
Outlook for 2023 and Beyond
Slide 24: Multiple Growth Catalysts in 2023
Multiple Growth Catalysts in 2023 Arimoclomol KP1077 Development Program Interim data from Phase 2 clinical trial expectedas early as Q3 2023 Top-line data expected by EOY 2023 Potential to initiate phase 3trial in narcolepsy following IH phase 2 trial results Expectto file IND in Q2 2023 fornarcole
Slide 25: Q&A
Slide 26: U. — [a4 > Lu N n oO (fo =) Ww a < a
U. — [a4 > Lu N n oO (fo =) Ww a < a Ww = (S k Yo AY an Th